A Phase II Trial to Evaluate the Use of Trental and Vitamin E for Prophylaxis of Radiation Necrosis
Overview
- Phase
- Phase 2
- Intervention
- Trental
- Conditions
- Brain Metastasis
- Sponsor
- University of Cincinnati
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Number of Participants With Symptomatic Radiation Necrosis
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to determine whether the use of Trental and Vitamin E can help reduce the incidence of radiation necrosis (a lesion that usually occurs at the original tumor site) after radiosurgery. These two drugs are commonly used to treat radiation necrosis when it occurs but the hope is that these drugs can be used to prevent radiation necrosis from ever occurring.
Detailed Description
The treatment phase of the study is 6 months. Study procedures will be conducted such as: history, physical and neurological exam, pregnancy testing (for women of child bearing age) and a Brain MRI. Follow-up appointments will be every 3 months for 1 year at which time, your participation in the study will be concluded.
Investigators
Michelle Marcum
Director, University of Cincinnati Cancer Center
University of Cincinnati
Eligibility Criteria
Inclusion Criteria
- •Plan to undergo single or five fraction radiosurgery for a metastatic brain tumor
- •Diagnosis of a metastatic brain tumor may be accomplished by histologic confirmation or by clinical confirmation by the treating physician based on MR imaging characteristics in the setting of a known history of cancer
- •Age \> 18 years
- •Partial or total resection of a metastatic tumor are eligible
Exclusion Criteria
- •Known sensitivity to vitamin E or Trental
- •Recent intracranial bleed or retinal hemorrhage
- •Treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment
- •History of Avastin treatment
- •Anticipated need for treatment with Avastin
- •History of bleeding disorder
- •History of liver disorder
Arms & Interventions
Trental + Vitamin E
Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment
Intervention: Trental
Trental + Vitamin E
Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment
Intervention: Vitamin E
Outcomes
Primary Outcomes
Number of Participants With Symptomatic Radiation Necrosis
Time Frame: average 1 year
Number of symptomatic death of healthy tissue caused by radiation therapy.